Validation Engineer

Job Title

Job Description

What You'll Do

Configures, tests, and validates electronic systems to ensure the systems are properly qualified and validated per standards and regulatory requirements (e.g., Food & Drug Administration (FDA))

Reads piping & instrumentation diagrams (P&IDs) to walkthrough systems in the field

Drafts and implements validation protocols

Executes validation activities (e.g., equipment set up, material readiness, and work orders)

Creates work orders, generates calibration reports, maintenance plans, and other items in the computerized maintenance management system (CMMS)

Executes and manages validation protocols for manufacturing equipment, lab and admin, process support equipment, etc.

Develops dashboards in Tableau to visualize and analyze CQV data to track progress and trends

Identifies and assesses risks and escalates to senior engineers or management to develop and implement mitigation strategies

Develops, implements, and maintains equipment and system qualifications and validation protocols

Prepares and presents report packages for implementation into standard operating procedures (SOPs)

Prepares validation master plans for facilities, equipment, and systems

Provides guidance to junior engineers for drafting and implementing validation studies

Collaborates cross-functionally to ensure successful integration of CQV activities into projects

Other duties, as assigned

Minimum Requirements

Bachelor's degree in Engineering with 5 years of experience in validation activities in facilities, commissioning, and systems qualification

Prior experience leading teams or projects

Temperature mapping, Thermal Data Loggers, and pre- and post-calibration procedure experience